Sterility Testing Culture Media & Rinsing Fluids

Sterility testing is a key GMP microbiology testing requirement for sterile pharmaceuticals, medical devices, and materials to ensure safety from viable microorganisms before release and administration. Sterility testing is required during the sterilization validation process, as well as for routine release testing. These tests are either carried out by direct inoculation or membrane filtration methods and can be performed in an isolator or cleanroom environment.

Steritest^® culture media and rinsing fluids

Compendial methods for the sterility testing of pharmaceutical products requires samples to be cultured using specific culture media. Our sterility testing media and rinsing fluids are critical components of Steritest^® solution. They provide the highest level of quality and testing confidence and have been formulated complying with the USP 71, EU Pharmacopoeia 2.6.1, and JP Pharmacopoeia 4.06 requirements. The culture media and rinse fluids used for sterility testing are manufactured in an ISO 9001, environmentally controlled production center. Each batch undergoes a stringent quality control (QC) procedure, including pH, sterility, and growth promotion tests following the USP, EP, and JP methods. Our manufacturing approach of culture media and rinsing fluids ensures the highest level of clarity, thus improving accuracy and significantly reducing the risk of false results.

Our Steritest^® culture media and rinsing fluids combined with our closed membrane filtration devices, peristaltic pump, and specific accessories offer an optimized and fully regulatory-compliant testing process.

STERILITY TESTING CULTURE MEDIA AND RINSE FLUIDS INCLUDE

• Sterility Testing Culture Media
• Sterility Testing Rinse Fluids & Solvent
• Double Packed Sterility Media & Rinse Fluids
• Customized Culture Media for Special Applications

Sterility testing culture media

Membrane filtration and direct inoculation are two recommended methods of sterility testing for pharmaceuticals, and this requires samples to be cultured in different culture media that can promote the growth of residual anaerobes, as well as aerobes and fungi. The samples are incubated for 14 days at 32.5 °C and 22.5 °C respectively, before the examination. The turbidity in the culture media may indicate growth and must be investigated. The commonly used culture media are:

Soybean-Casein Digest Medium (Trypticase Soy Broth, TSB) is a sterility testing media suitable for the detection of aerobic bacteria and fungi. The composition and growth performance of this medium comply with the USP, EP, and JP standards. It is also used as pre-enrichment broth for non-sterile products.

Fluid Thioglycollate Medium (FTM) is primarily intended for the detection of anaerobic bacteria. However, it also enables the detection of aerobic bacteria. The USP, EP, and JP have recommended the media for determining the phenol coefficient and sporicidal effect of disinfectants in antibiotics, biologicals, etc. However, it is intended for the examination of clear liquid or water-soluble materials.

Clear Thioglycollate Medium has the same growth promotion properties as the standard FTM and is compliant with the USP, EP, and JP. This alternative formulation brings extra visual clarity versus the FTM, which has slight turbidity or haze due to the presence of agar. A high visual clarity medium is preferred by many users when compared with the slightly turbid appearance of FTM.

Table 1. Sterility testing culture medium solution. Click on the product number to learn more.

Medium Solution Bottle	Closure	Volume (mL)	Qty/pk	Product Number
Trypticase Soy Broth, TSB (Soybean-Casein Digest Medium)	Screw cap with septum	100 mL	12	STBMTSB12
	Screw cap with septum – double packed	100 mL	12	STBMTSB12DP
	Crimp cap with septum	100 mL	10	1.46317
	Screw cap with 3 mini septa	100 mL	10	1.46458
	Tube, screw cap with 2 mini septa	9 mL	20	1.46432
	Tube, screw cap with 2 mini septa	9 mL	100	1.46432
Fluid Thioglycollate Medium, FTM	Screw cap with septum	100 mL	12	STBMFTM12
	Screw cap with septum – double packed	100 mL	12	STBMFTM12DP
	Crimp cap with septum	100 mL	10	1.46406
	Tube, screw cap with 2 mini septa	10 mL	20	1.46139
	Tube, screw cap with 2 mini septa	10 mL	100	1.46139
	Tube, screw cap with 2 mini septa	9 mL	20	1.46220
	Tube, screw cap with 2 mini septa	9 mL	100	1.46220
Clear Thioglycollate Medium, CTM	Screw cap with septum	100 mL	12	STBMCTM12
	Screw cap with septum – double packed	100 mL	12	STBMCTM12DP
	Crimp cap with septum	100 mL	10	1.46456
	Red screw cap and septum	100 mL	10	1.46333

Sterility testing rinse fluids and solvent

Rinse fluid is used as a diluting or rinsing solution for membrane filtration sterility testing in pharmaceutical products. Our ready-to-use rinse solutions provide the highest level of quality and testing confidence. They have been formulated and tested to meet the pharmacopeia requirements. Rinsing fluids are used for sterility testing of medical devices by flushing the hollow tubes, such as transfusion and infusion assemblies, where the fluid pathway is labeled as sterile.

Fluid A is suitable as a general rinse buffer and compatible with most samples. Excellent for dissolving or diluting samples, reconstituting commercial microorganisms, or as a transport medium for microorganisms.

Fluid D is suitable for testing samples that contain lecithin or oil and are compatible with most antibiotics. Excellent for rinsing sterile pathways of devices and typically used for rinse method testing of medical devices.

Fluid K is suitable for testing samples that contain petrolatum, oils, or oily solutions. Excellent for rinsing pathways of medical devices and for samples that are “difficult” to filter or dissolve.

Sterile Isopropyl myristate (IPM) is suitable for improving the dissolution of viscous products, ointments, and creams before membrane filtration.

Table 2. Sterility testing rinse fluid solution with packaging information. Click on the product number to learn more.

Rinse fluid solution bottle	Closure	Volume (mL)	Qty/pk	Product number
USP Rinse Fluid A	Screw cap with septum	600 mL	4	STBMRFA64
	Crimp cap with septum	600 mL	6	STBMRFA34
	Screw cap with septum	300 mL	4	STBMRFA34
	Crimp cap with septum	300 mL	6	1.46415
	Screw cap with septum	100 mL	12	STBMRFA12
	Screw cap with septum – double packed	100 mL	12	STBMRFA12DP
	Crimp cap with septum	100 mL	10	1.46470
USP Rinse Fluid D	Crimp cap with septum	300 mL	6	1.46483
	Screw cap with septum	300 mL	4	STBMRFD34
USP Rinse Fluid K	Screw cap with septum	300 mL	4	STBMRFK34
	Crimp cap with septum	300 mL	6	146415
Sterile Isopropyl myristate (IPM)	Crimp cap with septum	360 mL	6	146628

STERILITY TESTING DOUBLE-PACKED CULTURE MEDIA AND RINSE SOLUTIONS

The sterilized double Tyvek^® packaging helps to minimize the risk of cross-contamination in laminar flow hoods and to secure efficient decontamination of isolator chambers. These products are supplied as 100 mL screw cap bottles and screw caps with septum closure. The sterilization efficiency of the packaging, including the space between the protective cap and the septum, is verified on each batch with biological indicators. With the double-packed media and rinse solutions:

• Streamline and optimize the cleaning procedures
• Minimize the risk of cross-contamination and false results
• Reduce the bioburden load on the testing environment
• Secure efficient decontamination of isolator chambers

Table 3. Sterility testing culture media and rinse fluid solution with sterilized double Tyvek^® packaging. Click on the product number to learn more.

Medium and Rinse fluid bottle	Closure	Volume (mL)	Qty/pk	Product Number
Clear Thioglycollate Medium	Screw cap with septum – double packed	100 mL	12	STBMCTM12DP
Fluid Thioglycollate Medium	Screw cap with septum – double packed	100 mL	12	STBMFTM12DP
Trypcase Soy Broth (Soybean-Casein Digest Medium)	Screw cap with septum – double packed	100 mL	12	STBMTSB12DP
USP Rinse Fluid A	Screw cap with septum – double packed	100 mL	12	STBMRFA12DP

CUSTOMIZED CULTURE MEDIA FOR SPECIAL APPLICATIONS

We offer tailor-made products if none of the above products are appropriate for your application. Indeed, with the multipurpose filling lines, we can produce a wide range of customized products and volume sizes, as well as a large choice of bottle closures. You can adapt an existing formula or request a product with your individual formulation made from scratch.

A WIDE RANGE AND MULTIPLE FORMATS OF PRODUCTS FOR ALL YOUR STERILITY TESTING APPLICATIONS

Steritest^®culture media and rinse solutions are validated and packaged in convenient test volumes, with aseptically designed septum closures (screw caps or flip caps) for ease of operation, thus fulfilling all your sterility and bioburden testing needs.

Fluids A, D, and K can be used in combination with the Steritest^® sterility testing system or for bioburden testing to rinse membranes and dilute or dissolve samples. Detailed certificates of quality (COQ) are available to download from the website.

Sterile Isopropyl myristate (IPM) can be used in combination with the green Steritest^® canister.

"The use of double packed Steritest^® culture broths TSB and FTM for sterility testing is a great improvement in terms of sterility assurance, standardization and cost saving:

• Higher sterility assurance level thanks to the sterilized double packing
• Easier and faster cleaning procedures"

— PHAM Hoang, Biology QC Manager, Virbac, France

Complete Sterility Testing Solutions for Complete Confidence

Discover our full sterility testing portfolio based on over 45 years of experience and expertise. Our large variety of devices and pumps, along with sterile culture media and rinsing fluids can help you to stay compliant, whether you use membrane filtration or direct inoculation methods. Reduce the sterility testing workload and focus on your critical lab activities thanks to our extended Steritest^® services portfolio. The experienced application and validation engineers will assist in method development and validation implementation within the QC microbiology laboratory. They will also provide basic and advanced technical training on sterility testing, in person or remotely.

Brochure: Sterility Testing Complete Portfolio

 

Poster: Complete Solutions for Complete Confidence with the Steritest^® System

 

Pharma Microbiology Method Development & Validation